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Intended Use: MAYFIELD® Radiolucent Skull Pins are used with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surqical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MRI imaging is used.

Indications for Use: The MAYFIELD® Radiolucent Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MRI imaging of the patient is used.

The MAYFIELD Radiolucent Skull Pin 4-0-A-2020 [radiolucent pin] consists of the following components: a molded black-color ABS plastic base, and a machined sapphire-crystal pin point. The radiolucent pins are packaged three (3) pins per pouch, two (2) pouches per carton and EO sterilized. The radiolucent pins are single-use devices used to rigidly fix the patient's head and/or spine during surgery. The radiolucent pins are assembled from two components; a molded ABS plastic base [the same as used in the predicate device, MAYFIELD Disposable Skull Pins 4-0-A-1072][A1072 pins] and a pin point made of sapphire crystal that is machined to the same dimensions as the A1072 pin point. In preparation for surgery three (3) radiolucent pins are installed in a MAYFIELD Radiolucent Skull Clamp; two radiolucent pins in the Rocker Arm side and a single radiolucent pin on the opposite side. The radiolucent pins are EO sterilized, just as the A1072 pins mentioned above, and are ready for use right from the sterile pouch.

The provided document describes the acceptance criteria and a study comparing the MAYFIELD® Radiolucent Skull Pins (4-0-A-2020) to a predicate device, the MAYFIELD Disposable Skull Pins (4-0-A-1072, K923789).

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device were based on demonstrating substantial equivalence to the predicate device in terms of performance, with an additional benefit in CT/MRI compatibility.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a precise numerical sample size for the "test set" in terms of how many pins were tested for mechanical performance. It states "Multiple Penetration Tests" were run. For the CT imaging comparison, it mentions "CT Images of a melon held by radiolucent pins and a melon held by stainless steel pins." This suggests at least one comparison image set, but not a large, statistically robust sample.
• Data Provenance: The nature of the tests (mechanical and imaging on a melon) suggests these were lab-based, engineering tests rather than clinical data. Therefore, there's no mention of country of origin of data or whether it was retrospective or prospective. It is entirely prospective in the sense that the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for these tests was objective, quantifiable measurements of mechanical integrity and image artifact, not expert interpretation. For example, "no degradation of point" or "sustained side forces exceeding safety factor" are engineering standards, and "significantly less artifact" would be based on image analysis, not expert consensus on pathology.

4. Adjudication method for the test set

Not applicable. The tests performed are objective engineering and imaging comparisons, not involving human interpretation that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The tests described are for a medical device (skull pins), not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. The performance evaluation is for the physical device.

7. The type of ground truth used

The ground truth used was based on objective engineering measurements and imaging data analysis.

• For mechanical performance (Penetration Tests): The ground truth was defined by physical parameters such as "no degradation of point" and "sustained side forces exceeding safety factor of 2," which are quantifiable engineering metrics.
• For imaging compatibility: The ground truth was based on the direct comparison of image artifacts in CT scans, visually and potentially quantitatively assessed as "significantly less artifact."

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843.

This notification only relates to a revision of the Indications for Use to a closer alignment riflis notinoution only rolatoo to a rothfor the devices shown above to which Substantial Equivalence is claimed.

All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.

This 510(k) premarket notification (K013428) for the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System is a submission for a revised indication for use for an already cleared device. Therefore, it does not contain a new study that proves the device meets specific acceptance criteria related to performance metrics (e.g., accuracy, sensitivity, specificity).

The core of this submission is a claim of substantial equivalence to previously cleared devices (K981686, K003699, K001153, K005389) and a revision to the Indications for Use statement. It explicitly states: "The devices are not changed either in hardware or software. This notification only relates to a revision of the Indications for Use..."

As such, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, because a new study demonstrating such performance was not conducted or submitted with this specific 510(k). This particular submission leverages the performance established in the predicate devices and focuses on broadening the scope of its clinical utility.

Therefore, most of the sections of your request are not applicable to this document. I will fill in the information that is available.

Acceptance Criteria and Device Performance Study for K013428: MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System

This 510(k) submission (K013428) is for a revised indication for use of an existing device, the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System. The document explicitly states: "The devices are not changed either in hardware or software." and "This notification only relates to a revision of the Indications for Use..."

Therefore, this submission does not include a new study with specific acceptance criteria and reported device performance metrics (such as accuracy, sensitivity, specificity, detection rate, etc.) for a novel or modified device. The substantial equivalence is based on the previously cleared predicate devices and the unchanged hardware/software.

Table of Acceptance Criteria and Reported Device Performance:

Since no new performance study was conducted or presented in this 510(k), this table cannot be populated with new device performance against acceptance criteria. The device's performance is assumed to be consistent with the predicate devices and its prior clearances (K955397, K982244, K991267, and K992843).

1. A table of acceptance criteria and the reported device performance:

• Not applicable. This 510(k) does not present new performance data or acceptance criteria as it's for a revised indication of an existing, unchanged device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable. No new test set data was provided or generated for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. No new ground truth establishment was described for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No new adjudication method was described for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. The device described is a computer-based image-guided stereotactic planning system, not an AI-assisted diagnostic device where "human readers improve with AI vs without AI assistance" would be a relevant metric. Furthermore, no MRMC study was mentioned in this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This submission focuses on a revision of indications for use for an existing surgical navigation system. Standalone algorithm performance, in the context of typical AI/diagnostic devices, is not relevant here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No new ground truth establishment was described for this submission. For surgical navigation systems, the 'ground truth' often relates to the physical accuracy of the navigation relative to anatomical landmarks, but no new study measuring this was presented.

8. The sample size for the training set:

• Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.

9. How the ground truth for the training set was established:

• Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.

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The Systems are intended for use as: devices that, by the use of diagnostic images of the patient, acquired specifically to assist the surgeon with presurgical planning, provide orientation and reference information during intra-operative procedures.

The Systems are indicated for use in: Guidance and localization in open craniotomies, and for surgeries that are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies, and electrode implants. The Systems may also be used to review medical images in a neurosurgical context.

The MAYFIELD®/ ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and MAYFIELD® Optical ACCISS™ System with Windows NT® for Cranial Surgery and with the Wireless Probe/DRF are modifications to existing systems. The modifications involve converting the operating system software to Windows NT from DOS and adding a battery-powered Wireless Probe and battery-powered Wireless Dynamic Reference Frame for use with the Optical System. The systems use diagnostic images of the patient for presurgical planning and provide orientation and reference information during intra-operative procedures. The systems utilize either arm or optical tracking for 3-D digitizing, interface to a computer graphics workstation, display reformatted CT or MR images, and use algorithms for image-guided surgery planning.

The provided text is a 510(k) Summary for a medical device (MAYFIELD®/ACCISS™ System), describing modifications to existing systems. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and studies (like sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not present in this document.

However, based on the provided text, I can extract information related to the device's performance demonstration for substantial equivalence.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify formal "acceptance criteria" in terms of quantitative performance metrics (e.g., accuracy thresholds, sensitivity/specificity targets) for the new modifications. Instead, the "performance" demonstrated is that the modifications (Windows NT software and Wireless Probe/DRF) did not change the functionality of the systems compared to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only states that "Tests simulating cranial surgery planning were performed." It does not specify the number of tests, the type of data (e.g., patient data, simulated models), or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The text does not mention the use of experts to establish a "ground truth" for the testing in the context of clinical performance. The comparison was against the functional performance of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable and not performed. The device described is a computer-based image-guided surgical planning system, not an AI diagnostic tool primarily impacting human reader performance. The modifications were to the operating system and a wireless accessory.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance evaluation in the typical sense of AI algorithms is not described. The "tests simulating cranial surgery planning" would inherently involve the system's functionality, but the document doesn't detail performance metrics like accuracy, precision, or error margins for the system itself. The focus was on comparing the modified system's operation to the predicate system's operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" in the context of clinical outcomes or diagnostic accuracy is not applicable to the described study. The study involved a functional comparison; the "ground truth" for these tests was the expected behavior and output of the predicate devices.

8. The sample size for the training set

This is not applicable and not provided. This document pertains to modifications of an existing image-guided surgery system, not the development or training of an AI algorithm from a training set.

9. How the ground truth for the training set was established

This is not applicable and not provided.

Summary of the Study (as described in the document):

The study performed was a comparative functional validation.

• Study Design: The manufacturer performed "Tests simulating cranial surgery planning" using the modified systems (Arm System with Windows, Optical System with Windows and Wireless Probe/DRF).
• Comparison: The results of these tests were "compared to the results of the same tests performed with the DOS-based Systems and with the wired Probe and DRF" (the predicate devices).
• Objective: To demonstrate that the "functions of the Arm and Optical Systems were unchanged" despite the modifications.
• Conclusion: Based on this comparison, the manufacturer concluded that the modifications "do not raise any new unresolved issues relating to safety and effectiveness" and that the modified systems are "substantially equivalent to the predicate Systems."

Essentially, the study aimed to show that changing the operating system and adding a wireless accessory did not alter the fundamental, proven functionalities of the existing medical devices.

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The MAYFIELD®/ ACCISS™ Image-guided Stereotactic Workstation and the MAYFIELD®/Optical ACCISS™ Image-guided Stereotactic Workstation (OASYS"), are indicated for use in guidance and localization in open craniotomies and in spinal surgeries. The ACCISS™ Systems are indicated for any medical condition in which the use of stereotactic surgery may be considered safe and effective, and where a reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

Spine Applications is software that allows the user to select ("crop") images of the portion of the spine under consideration from images of the entire spinal column. Also included is an accessory, the MAYFIELD® ACCISS" Spine Ring" Assembly (hereafter referred to as Spine Ring). The indications for use of the Arm and Optical Systems have been expanded to include use in spinal surgeries.

With Spine Applications, the Arm and Optical Systems can be used to identify spinal anatomical landmarks on the preoperative patient scans and also on the patient's spine to achieve registration with the imaged data set. After the correlation, the indication of the probe orientation appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon. This is the same process as that used in cranial surgery with the Systems.

Spine Applications, in conjunction with the Arm and Optical Systems, is a computer-based system designed for use in the surgical theatre. The Arm System uses a position-sensing articulated Arm with a probe that acts as a localizing device. The Optical System uses a Sensor Assembly positioned above/beside the surgical site that tracks the position and orientation of digitizing probes and other instruments.

To use either System, the computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points of anatomical landmarks. The System computer interfaces with CT or MR images and provides probe orientation/ probe-tip position. The indication of the probe orientation and probe-tip position appears on the monitor screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.

Here's an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices for a software module (Spine Applications) and an accessory (Spine Ring) that expand the indications for use of existing image-guided stereotactic workstations to include spinal surgery. It does not define explicit, quantitative acceptance criteria or report specific performance metrics for the device against such criteria.

Instead, the performance section states:

• "The Spine Applications performed to the surgeons' satisfaction with regard to preoperative planning and accuracy."
• "The clinical data for Spine Applications compared favorably with the data for cranial surgery performed using the Systems."

This indicates a qualitative assessment of surgeon satisfaction and a comparative assessment with existing cranial surgery data (which itself is not detailed here for performance metrics).

Therefore, a table of explicit acceptance criteria and corresponding numerical performance cannot be constructed from the provided text.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The text mentions "The Arm System and the Optical System, both with Spine Applications, were used by surgeons under authority of the Institutional Review Boards for the hospitals involved." This implies clinical use, but the number of cases or patients is not specified.
• Data Provenance: The study was conducted under the authority of Institutional Review Boards (IRBs) for "the hospitals involved," indicating a clinical setting. It is implied to be a prospective use study given it was done by surgeons with the new applications. The country of origin is not specified but is likely the USA given the FDA 510(k) context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not specified.
• Qualifications of Experts: The text states the systems "were used by surgeons," implying that these surgeons acted as the experts in evaluating the device's performance. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed.

4. Adjudication Method for the Test Set:

• The text does not describe any formal adjudication method (e.g., 2+1, 3+1). The evaluation appears to be based on the "satisfaction" of the surgeons using the device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared, nor is an "effect size" mentioned. The study focused on surgeon satisfaction and comparison to cranial surgery data rather than measuring improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• This device is an image-guided surgery system where a human surgeon is inherently "in-the-loop." The software (Spine Applications) provides guidance to the surgeon. Therefore, a standalone (algorithm-only) performance study, in the typical sense of evaluating diagnostic AI, would not be applicable or described for this type of device. The evaluation is on the system's utility and accuracy when used by a surgeon.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• The "ground truth" implicitly used for evaluation was the surgeons' assessment of the "satisfaction with regard to preoperative planning and accuracy" during actual surgical procedures. This can be interpreted as a form of expert assessment/clinical utility in a real-world surgical context, rather than a quantifiable, independent ground truth like pathology or long-term outcomes data.

8. The Sample Size for the Training Set:

• The document does not describe the development or training of new algorithms (AI in the modern sense) with a training set. Instead, it states that "Spine Applications provides the surgeon with image-guided technology, using the identical algorithms currently used for cranial image-guidance." This implies that existing, validated algorithms (presumably for cranial surgery) are being reused or adapted for spinal applications. Therefore, no separate "training set" for new spine-specific algorithms is mentioned.

9. How the Ground Truth for the Training Set Was Established:

• As no new training set or algorithms are described for Spine Applications, the establishment of ground truth for a training set is not applicable or detailed in this document. The existing algorithms from the predicate cranial devices would have had their own validation and associated ground truth established during their original development, which is outside the scope of this 510(k) summary.

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The OMI® Occipital Cervical Loop is intended to be used to assist stabilization and fusion of the cervical spine and cervical occipital junction.

1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies).
2. Spondylolisthesis of the cervical vertebrae.
3. Spinal stenosis of the cervical vertebrae.
4. Atlanto/axial fracture with instability.
5. Cervical-occipital dislocation.
6. Revision of previous cervical fusion surgery.
7. Tumors.

The OMI® Occipital Cervical Loop, Catalog Number A-1089, consists of the following components: Cervical Support Loop, Cross Link, Compression Blocks (2), Cervical Support Nuts (2), and an implantation instrument, the Cervical Support Wrench [11mm].

The OMI® Occipital Cervical Loop is a single-use, permanent device used to assist in stabilization and fusion of the occipital cervical region of the spine. It consists of the Cervical Support Loop [CSL], a contoured rod made of biocompatible titanium having an alloy composition of 6AL-4V ELI, according to ASTM-F136. The CSL is U-shaped, with a circular loop at one end and two free lengths extending lengthwise, parallel to each other, from the loop end. The profile of the CSL resembles that of a normal cervical lordosis from the cervical region of the spine to the occiput of the skull. The Cross Link can be attached to the free end lengths of the CSL for additional rigidity. The Cross Link is flat, with a slot at each end, and can be attached to the CSL with the Compression Blocks and Cervical Support Nuts. The Cross Link, Compression Blocks, and Cervical Support Nuts are also made from 6AL-4V ELI titanium.

These titanium alloy implants are designed for use with multi-filament braided titanium alloy [6Al, 4V] cable, .045 inch [1.1 mm] diameter, 19 inches in length, with a pure, soft titanium mono-filament lead wire 3 inches in length. This wire is Sofamor Danek Catalog # 826-360, the same type of wire cleared for use with Sofamor/Danek spinal devices.

This document describes the 510(k) submission for the OMI® Occipital Cervical Loop, a spinal implant. The primary method for proving substantial equivalence to a predicate device (Ransford Cervical Fixation System™) is through performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OMI® Occipital Cervical Loop are implicitly defined by performing "substantially the same" as the predicate device, the Ransford Cervical Fixation System™, in static and fatigue testing. The table below summarizes the comparative performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Static Tests: Five (5) tests were run for the OMI® Occipital Cervical Loop and five (5) tests for the predicate device.
  • Fatigue Tests: Six (6) tests were run for the OMI® Occipital Cervical Loop and six (6) tests for the predicate device.
• Data Provenance: The data is prospective, generated specifically for this 510(k) submission through physical testing of the devices. The country of origin for the testing data is not explicitly stated in the provided text, but the applicant is Ohio Medical Instrument Company, Inc. in Cincinnati, Ohio, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable. The study involves physical testing of the device, not a diagnostic or AI-based system requiring expert consensus on a test set.

4. Adjudication Method for the Test Set

This section is not applicable, as there is no human-based assessment or diagnostic task requiring adjudication. The results are from mechanical laboratory tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a physical spinal implant, and the study focuses on its mechanical performance compared to a predicate device, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study is the objective mechanical performance of the devices under controlled laboratory conditions. This includes measurements of stiffness, static strength, and fatigue life.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning model but a physical product undergoing mechanical performance testing.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for a physical device undergoing mechanical performance testing.

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Intended Use: The Optical Tracking ACCISS™ System is intended to be used in an identical manner as the predicate device (Mayfield®/ACCISS™ Stereotactic Workstation). It is used for guidance and localization in open craniotomies and for surgeries, which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.

The Optical Tracking ACCISS™ System is a computer-based system designed for use in the surgical theatre. It is a mobile design with the majority of the system components being self-contained in a cart. The camera assembly is separate from the cart components and it must be positioned above or beside the surgical site, preferably on a tripod or dedicated camera stand. The camera assembly tracks the position and orientation of digitizing probes and other instruments. The computer is loaded with the patient's computed tomography (CT) or magnetic resonance image (MRI) data and these images are correlated to the patient by physically matching points, such as scanned fiducial markers, anatomical landmarks, or surface features. The host computer, interfaced with CT and /or MRI images, provides probe position and orientation. The probe manipulation by the surgeon appears on a monitor as it moves through space. Three light-sensing cameras, the positions of which are known with respect to a predetermined coordinate system, detect the positions of at least two light-emitting diodes positioned on the probe. The cameras and probe transmit data to a computer and the position and orientation of the probe is determined relative to the coordinate system. The probe tip position is determined by correlating the tip position with the position of a scanned image of the object, both tip position and scanned image being defined relative to the predetermined coordinate system. A monitor connected to the computer indicates the location of the probe tip on the scanned image by displaying a representative location of the tip with respect to the model of the object. The Optical Tracking ACCISS™ System consists of the following: A. Workstation B. Software C. Probe Assembly D. Training Accessories (1) Plastic Skull 50 CT/MRI Fiducial Markers

This acceptance criteria and study information is not available in the provided text. The document is a 510(k) submission summary for the Mayfield® ACCISS™ Optical System, which focuses on establishing substantial equivalence to a predicate device. It describes the intended use, device description, and comparison to the predicate device in terms of indications, design, materials, manufacturing, and specifications.

However, it does not contain details about specific performance acceptance criteria or a study designed to prove the device meets such criteria. The document states that "No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act." This implies that the submission relies on substantial equivalence rather than meeting specific quantifiable performance benchmarks through a dedicated performance study.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set information as this information is not present in the provided text.

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The TEW Cranial Spinal Retractor (A-1090) is designed for posterior fossa or intraspinal microsurgery where retraction is required.

TEW Cranial/Spinal Retractor™ is made from titanium and the blades, micro-retractors and flexarm assemblies are made from stainless steel. It has two movable arms, which operate independently by rotating a worm on a worm gear thus allowing an acme threaded shaft to translate through the worm gear (Patent pending). The mechanism of the TEW Retractor is self locking due to the worm/worm gear design. A hex wrench is used to drive the system. TEW Retractor blades can be pre-attached to the arms outside of the wound and a formed locking edge on the blades prevent them from falling off. The blades can also be pre-positioned and once retraction has been initiated, blades will remain in a fixed position. TEW Retractor micro-retraction is accomplished by unrestricted placement of the flexarm assemblies along the entire length of the retractor arms. There is no limit to the number of flexarms that can be used.

The provided document is a 510(k) premarket notification for a medical device, the "TEW Cranial/Spinal Retractor™". As such, it does not describe a clinical study in the traditional sense with acceptance criteria and device performance metrics against a ground truth, as would be expected for an AI/ML medical device or a diagnostic device.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove clinical efficacy through a detailed study. Therefore, most of the requested information (sample size, experts, adjudication, MRMC, standalone performance, training data, etc.) is not applicable to this type of submission.

Here's an analysis of the provided text based on the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device in terms of indications for use, design, materials, manufacturing processes, and specifications, such that no new questions of safety or effectiveness are raised. There are no specific quantitative performance metrics provided that would typically populate such a table for a diagnostic or AI device.

Reported Device Performance:
The document describes the device's features and how they compare to the predicates, highlighting similarities and some design improvements, but does not present quantitative performance data from a study.

• TEW blades can be pre-attached and have a formed locking edge (vs. Karlin blades which lack this).
• TEW allows unrestricted placement and number of flexarm assemblies (vs. Karlin's single slide holder for two retractors; Apfelbaum's fixed posts for two flexarms). |
  | Materials are substantially equivalent | TEW Retractor: Titanium frame, stainless steel blades and flexarm assemblies (vs. Karlin: all stainless steel; Apfelbaum: all stainless steel). The difference in frame material (titanium vs. stainless steel) is presented as not raising new safety/effectiveness issues. |
  | Manufacturing processes are equivalent | The manufacturing processes (milling, wire cutting and forming) are the same as those used in the predicate devices. |
  | Specifications are equivalent | The specifications of the TEW Cranial Retractor™ are the same as those of the predicate devices. |
  | No new issues relating to safety and effectiveness are raised | Conclusion: "The indications, design, materials, manufacturing and specifications of the TEW Cranial/Spinal Retractor™ do not raise any new issues relating to safety and effectiveness." |

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This is a 510(k) submission for a mechanical surgical retractor. It does not involve a "test set" of data in the sense of a diagnostic or AI device. The submission relies on design comparisons, material compatibility, and manufacturing process equivalence to established predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. There is no "ground truth" to establish for this type of device in the context of a 510(k) as there is no diagnostic outcome being evaluated. The safety and effectiveness are inferred from equivalence to existing devices.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This device is a surgical instrument (retractor), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. For a 510(k) of this nature, the "ground truth" for safety and effectiveness is primarily established through the long-standing safe use and regulatory clearance of the predicate devices. The submission asserts that the new device shares sufficient characteristics with these predicates.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. No training set exists.

In summary: The provided document is a regulatory submission for a medical device (a surgical retractor) seeking market clearance through the 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to existing, legally marketed devices rather than conducting clinical trials or performance studies with "acceptance criteria" and "ground truth" as would be done for novel diagnostic tools or AI/ML-powered devices. Therefore, most of the detailed questions about study methodology are not relevant to this type of documentation.

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